Phase I, II, III CTM & Commercial Scale (1kg up to 400kg)

///Phase I, II, III CTM & Commercial Scale (1kg up to 400kg)
Phase I, II, III CTM & Commercial Scale (1kg up to 400kg)2018-01-12T20:25:01+00:00

At VxP Pharma, our experienced scientists can offer complete guidance for manufacturing practically every dosage form available with strict quality compliance.  We have a comprehensive and full-service operation for clinical trial materials preparation in support of Phase I – III development and commercial scale-up.  Our services are cGMP compliant and include established protocols, efficient documentation practices, and effective QA management.

Process Development

During the development process, VxP Pharma will propose a manufacturing schedule for clinical trial supplies, based on API availability and your specific needs.  Our process team will develop and optimize production that can be scaled up efficiently within our cGMP facility.

Whatever your project, we can provide quick and customized solutions for:

  • Blending/homogenization
  • Filtration
  • Filling
  • Container/closure selection
  • Lyophilization
  • Manufacturing Scale-up and Technology transfer
  • A wide range of analytical and testing services
  • Placebo and complex formulations

Process Qualification

VxP Pharma follows FDA guidance and incorporates current methods of process validation for the production of drug products. Additionally, cleaning verification studies are conducted and fully documented for each process. Call us today for details.

Custom Manufacturing

Whether it is dosage aesthetics, special packaging requirements, or fast-track timelines, VxP Pharma will communicate with you throughout the entire project path in order to meet and exceed your expectations.

Full cGMP Compliance

Compliant with Title 21 CFR part 11, all data is inspected and quality audited to ensure full cGMP manufacturing compliance, accountability and document traceability.

Our state-of-the-art labs are staffed by some of the best trained and most experienced subject matter experts in the field.

Contact us today for a free consultation with our scientific team and discover how VxP can be a valuable resource and partner for your organization.